TracPatch Wearable Device for Knee Replacement Surgery Recovery

Overseen By Victor B Hernandez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnant, Prisoners, Complex arthroplasty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the TracPatch Wearable Device treatment for knee replacement surgery recovery?

Research shows that wearable devices, like the TracPatch, are feasible for monitoring recovery after knee replacement surgery, although more evidence is needed to confirm their effectiveness in improving patient outcomes. ^{1 2 3 4 5}

Is the TracPatch wearable device safe for use in humans?

The available research does not provide specific safety data for the TracPatch wearable device, but it suggests that wearable devices for knee replacement recovery are generally feasible and well-received by patients, indicating a level of safety in their use. ^{1 4 5 6 7}

How does the TracPatch wearable device differ from other treatments for knee replacement surgery recovery?

The TracPatch wearable device is unique because it continuously monitors knee range of motion and physical activity using sensors, providing objective data to help adjust rehabilitation programs. This differs from traditional methods that rely on manual measurements and offers a more personalized and flexible recovery process. ^{1 4 8 9 10}

Research Team

Victor H Hernandez, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults over 18 who are about to have knee replacement surgery due to osteoarthritis and can consent. They must be able to use a smartphone with Bluetooth. It's not for those who've had the same surgery on that knee, have severe knee deformities, or complex cases as judged by their surgeon.

Inclusion Criteria

Have signed the written informed consent form

Have consistent access to an iOS or Android device with Bluetooth capability

I am eligible for a total knee replacement surgery.

Exclusion Criteria

Wards of the state

I have had a total knee replacement on the same knee before.

My joint is bent or twisted more than 10 degrees.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Consensus TracPatch wearable device postoperatively and are instructed on its use for six weeks

6 weeks

Regular monitoring via wearable device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Consensus TracPatch

Trial Overview The study tests the Consensus TracPatch, a wearable device tracking recovery after knee surgery using motion and temperature sensors. It aims to improve post-op mobility and patient-doctor communication by providing real-time data.

Participant Groups

Group I: Wearable Technology Group Experimental Treatment 1 Intervention

Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Group II: Current Standard of Care Group Active Control 1 Intervention

Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Consensus Orthopedics

Collaborator

Trials

1

Recruited

150+

Findings from Research

Patients using a front-wheeled walker after total knee replacement (TKR) surgery demonstrated faster walking velocity and longer step lengths immediately after surgery compared to those using a standard walker, indicating a potential short-term benefit in mobility.

However, by six weeks post-surgery, both walker groups showed similar improvements in walking speed and endurance, suggesting that while the wheeled walker may aid initial recovery, it does not lead to greater long-term ambulation benefits or reduced therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. Pasquini, SM., Peterson, ML., Rattansi, SM., et al.[2010]

A new wearable device was developed to measure joint flexion and physical activity, showing strong correlation with traditional motion capture systems, making it a reliable tool for assessing post-operative recovery.

In a study with pigs after knee surgery, the device revealed that physical activity decreased immediately post-surgery but returned to pre-operative levels within two weeks, highlighting its potential for monitoring recovery in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Magnet-Based System to Assess Activity and Joint Flexion in Humans and Large Animals. Qu, F., Stoeckl, BD., Gebhard, PM., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of gait recovery after total knee arthroplasty using wearable inertial sensors: A systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. [2010]

3. India pubmed.ncbi.nlm.nih.gov

Accelerometer-based navigation improves early patient-reported outcomes after gap-balanced total knee arthroplasty. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A review of wearable motion tracking systems used in rehabilitation following hip and knee replacement. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A non-randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydropolymer wound dressing and smartphone technology: The EDISON trial protocol. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Patient Perceptions of Wearable and Smartphone Technologies for Remote Outcome Monitoring in Total Knee Arthroplasties. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A wearable mobility assessment device for total knee replacement: A longitudinal feasibility study. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Comparison of alignment and operative time between portable accelerometer-based navigation device and computer assisted surgery in total knee arthroplasty]. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Data Collection and Analysis Using Wearable Sensors for Monitoring Knee Range of Motion after Total Knee Arthroplasty. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A Wearable Magnet-Based System to Assess Activity and Joint Flexion in Humans and Large Animals. [2019]